Key result
The DECADE intervention is currently being evaluated in a pilot randomized controlled trial to determine its feasibility, usability, and potential effects on patient activation for reducing 10-year cardiovascular risk.
Why the study?
Does the DECADE intervention improve patient activation and reduce cardiovascular risk factors in primary care patients with at least one cardiovascular risk factor?
RCT (n=90)
Open-label
Stratified by GP practice
Yes
Does the DECADE intervention improve patient activation and reduce cardiovascular risk factors in primary care patients with at least one cardiovascular risk factor?
This pilot study protocol outlines a randomized trial to evaluate the feasibility and initial efficacy of a comprehensive, patient-centered decision aid and action planning intervention (DECADE) for cardiovascular risk reduction in primary care.
May inform primary care decision aid use if feasible; leaves open effects on patient activation and 10-year CV risk.
BACKGROUND: A healthy lifestyle can reduce cardiovascular risk (CVR) and prevent premature death. Usually most patients at increased CVR have difficulties implementing the necessary health behavior changes, such as smoking cessation, increasing of physical activity, healthy diet, stress reduction, etc. In this pilot study, a new intervention (DECADE) that includes a cardiovascular risk calculation, evidence-based decision aids, action planning, and follow-up support for patients to reduce their 10-year risk of cardiovascular diseases will be tested in primary care. The objectives of this trial are to test (1) the feasibility of the study design in preparation for the main trail including (2) the usability and acceptance of DECADE, and (3) initial data to ascertain that changes can be observed in these patients. METHODS: This randomized controlled pilot trial will generate initial data on the potential effects of DECADE on patients' self-evaluated activity and behavior change as well as on clinical outcomes such as blood pressure, cholesterol, body mass index (BMI), HbA1C, and CVR score. In the qualitative part of the study, we will analyze data collected in semi-structured interviews with participating general practitioners (GP) and in patient questionnaires. DISCUSSION: The outcomes of this pilot study will indicate whether DECADE is a promising intervention in the domain of patient-centered prevention of cardiovascular diseases (CVD) and whether a larger multi-center randomized controlled trial is feasible. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00010584.
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Tinsel et al. (2017) conducted an RCT in Cardiovascular risk (n=90). DECADE intervention (decision aid, action planning, and follow-up support) vs. Arriba calculator alone (waiting list control) was evaluated on Change in patient activation measure (PAM-13D) score between baseline and 4 months. The DECADE intervention is currently being evaluated in a pilot randomized controlled trial to determine its feasibility, usability, and potential effects on patient activation for reducing 10-year cardiovascular risk.
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